FDA EIR - Element Materials Technology Pharma USA LLC - May 03, 2019

An FDA surveillance inspection of Element Materials Technology Pharma USA LLC (formerly Exova Inc.), a contract testing laboratory in Santa Fe Springs, CA, was conducted from May 1-3, 2019. This inspection, carried out under regulatory frameworks for animal and human drug manufacturing, identified two primary deficiencies, resulting in a 2-item FDA Form 483.

The first observation concerned the firm's control over purchased water used in chromatography analyses, specifically for USP<467> Residual Solvent tests. Violations included failing to implement established procedures for incoming material control, lack of Quality Assurance review and release of the water, inadequate documentation of lot numbers in testing records, and deficient qualification of the water vendor. These issues contravened requirements for established standards and laboratory control mechanisms.

Secondly, the inspection noted a lack of adequate training for Quality Assurance reviewers on electronic data and audit trail review. Furthermore, the firm failed to routinely perform these essential reviews for GMP sample analyses, with many QA data audit forms incorrectly marking audit trail review as "not applicable" without justification. This indicated a deficiency in employee training regarding specific operational functions.

The General Manager, Dr. Jihye Jang-Lee, was issued the FDA Form 483 and committed to providing a written response to the observations within 15 business days, acknowledging the identified issues and promising corrective actions.